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Regulatory concerns remain despite industry's quick adaptation of decentralized trials.
As we continue to keep our eye on decentralized trials advances, a recent survey released by Oracle, and detailed in a recent webinar from Applied Clinical Trials showed that 76% of 252 industry respondents noted that the pandemic sped their adoption of decentralized clinical trial methods. The most common decentralization steps taken were patient-facing technologies or alternatives (64%), protocol redesign (63%), and investigator-facing technologies or alternatives (53%).
However, it is data issues and regulatory concerns that held most back from adopting decentralized trial methods—specifically, ensuring data reliability and quality and data collection. Also, to wearable and remote monitoring, the respondents’ top concerns are a different approach to review, manage, and interpret data (50%), expense (46%), and complicated regulatory considerations (41%). Additionally, from the 24% of respondents who reported that the pandemic had not accelerated their adoption of decentralized clinical trials, regulatory concerns (42%) were a top reason.
During Informa’s Clinical Trials in Europe virtual event, the panel discussion “The Future of Clinical Trials” was heavily weighted toward the many advances in technology used in clinical trials during COVID, and practices such as decentralized trials. Panel members Kenneth Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, and Kai Langel, Director, Janssen Clinical Innovation, took a moment to discuss whether industry will continue with its advances post-COVID.
Langel reiterated that as a global experiment, aspects brought forward by COVID are working out and regulators are OK with many of the changes, and, therefore, what’s successful will remain. He suggested that protocol deviations during COVID were not perfect but we can learn from that. “There will be data points that worked extremely well, and those that will show how they could improve,” Langel maintained.
Getz admittedly offered a “somewhat cynical” perspective based on historical data. “I think a lot of change in behavior in response to the pandemic may be more of a short-term or one-time occurrence, even though it has facilitated much more widespread use of many approaches supportive of the remote and virtual clinical trial activity,”
Based on an audience poll around barriers to decentralized trials, Langel expressed surprise that no one pointed out costs related to decentralized trials, saying costs will go up. “Home nursing is an expensive service as opposed to asking patients to travel to site,” he said. “But in many studies, such as rare diseases, the research gets done faster and better, so that trade-off can be worth it.”
Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at firstname.lastname@example.org.